Intellectt Inc · 1 day ago
CQV/Validation Engineer
Intellectt Inc is seeking a CQV / Validation Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing systems. This role will ensure compliance with FDA, cGMP, and global regulatory requirements throughout the system and process lifecycle.
Responsibilities
Develop and execute DQ, IQ, OQ, and PQ protocols for manufacturing equipment, cleanrooms, and GMP utilities (HVAC, WFI, PW, compressed air)
Support process validation, cleaning validation, and computerized system validation (CSV) activities
Ensure compliance with FDA 21 CFR Parts 210/211, 21 CFR Part 11, and EU GMP requirements
Support deviations, CAPA, and change control related to validation activities
Support internal and regulatory audits and maintain validation master plans (VMPs) and validation documentation
Collaborate with Engineering, QA, Manufacturing, and IT teams during project and lifecycle phases
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
3–7+ years of CQV/Validation experience in pharmaceutical or GMP-regulated environments
Strong knowledge of cGMP, GAMP 5, FDA, and EU GMP requirements
Experience with validation documentation systems and electronic quality systems
Company
Intellectt Inc
Intellectt Inc.
H1B Sponsorship
Intellectt Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (271)
2024 (255)
2023 (312)
2022 (372)
2021 (217)
2020 (134)
Funding
Current Stage
Late StageCompany data provided by crunchbase